MedTrace Logo

Sonodynamic Therapy on Patients With Femoropopliteal PAD and Claudication

NCT03318484 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-23

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing atherosclerotic plaques inflammation and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.

Conditions

Interventions

DRUG

Optimal Medical Care

Aspirin 100mg once a day, Atorvastatin 20mg once a day and Antihypertensive Agents if necessary.

COMBINATION_PRODUCT

Sonodynamic therapy

SDT treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg). The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.8W/cm2 for femoral lesions, resonance frequency: 1.0 MHz and duty factor: 30%.

Sponsors & Collaborators

  • Harbin Medical University

    collaborator OTHER

  • First Affiliated Hospital of Harbin Medical University

    lead OTHER

Principal Investigators

  • YE TIAN, MD, PhD · First Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2019-11-30
Completion
2019-11-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318484 on ClinicalTrials.gov